Study Coordinator Pleads Guilty in Scheme to Falsify Clinical Drug Trial Data
A Colorado man pleaded guilty today in connection with his participation in a scheme to falsify clinical drug trial data.
Duniel Tejeda, 35, of Canon City, Colorado, and formerly of Miami, Florida, pleaded guilty before U.S. District Judge Robert N. Scola Jr. of the Southern District of Florida to conspiracy to commit mail and wire fraud. According to court documents, Tejeda worked at Tellus Clinical Research, a medical clinic based in Miami. Tejeda served as a project manager and study coordinator for clinical drug trials. As part of his plea agreement, Tejeda admitted that he agreed with others to falsify data in medical records in connection with clinical trials intended to evaluate various medical conditions, including opioid dependency, irritable bowel syndrome and diabetic nephropathy. Among other things, Tejeda falsified data to make it appear as though subjects were participating in the trials when, in truth, they were not.
“The defendant’s conduct put profits before public health,” said Acting Assistant Attorney General Brian M. Boynton of the Justice Department’s Civil Division. “The Justice Department will continue to work with its partners at the Food and Drug Administration to investigate and prosecute anyone who engages in this conduct.”
“The public relies on the accuracy and honesty of clinical trial data,” said U.S. Attorney Juan Antonio Gonzalez for the Southern District of Florida. “Falsifying clinical data not only violates the public’s trust, it also endangers the safety of consumers. Those who unlawfully profit by compromising the public’s health in this way commit serious crimes and will be prosecuted.”
“FDA’s evaluation of a new drug begins with an analysis of reliable and accurate data from clinical trials,” said Assistant Commissioner for Criminal Investigations Catherine A. Hermsen of the Food and Drug Administration's (FDA) Office of Criminal Investigations. “Compromised clinical trial data could impact the agency’s decisions about the safety and effectiveness of the drug under review. We will continue to monitor, investigate and bring to justice those whose actions may subvert the FDA approval process and endanger the public health.”
Tejeda faces a maximum penalty of twenty years in prison. The court scheduled a sentencing hearing for Jan. 20, 2022. A federal district court judge will determine any sentence after considering the U.S. Sentencing Guidelines and other statutory factors.
The FDA's Office of Criminal Investigations is investigating the case.
Trial Attorneys Lauren M. Elfner and Joshua D. Rothman of the Justice Department’s Consumer Protection Branch are prosecuting the case. The U.S. Attorney’s Office for the Southern District of Florida has provided critical assistance.